Category: News

Submissions Relying on Third-Party Data (SRTD) – Health Canada Background

In 2015 Health Canada introduced the Submissions Relying on Third-Party Data (SRTD), a new regulatory pathway to submit New Drug Submissions (NDSs) or Supplements to NDSs (SNDSs) for market approval of pharmaceuticals, biologics, and radiopharmaceuticals. The primary draw of an SRTD is that it substantially relies on literature and market experience and does not rely …

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Lead in Drinking Water

The level of public concern related to lead in drinking water is high, due to the reports of community exposures reported in the media in recent years. While the various governmental organizations in Canada and the US have lead-management strategies in place, the situation is complex. Why is lead present in drinking water? Lead is present …

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Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me?

Perfluoroalkyl Substances (PFAS) – What are they and how do they affect me? What are PFAS? Perfluoroalkyl substances (PFAS) represent a group of man-made fluorinated organic compounds that are highly stable and persistent in the environment. These compounds have been used in industrial applications and consumer products since the 1950s, and many different PFAS have …

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Risk Assessment and Traditional Food Consumption

Traditional foods play an important nutritional, social, cultural and economic role for Indigenous Peoples in Canada.  This is particularly true in isolated northern communities where access to store-bought, nutrient-rich foods may be limited due to a lack of availability, lower quality and/or high costs. Traditional food refers to those foods that are harvested from the local environment, …

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Planning to File Your 505(b)(2) Product in Canada?

Canada may not be top of the list of countries that companies target for first registration of their product (although it may be for orphan drugs – however, that’s a subject for another day!), but it’s usually in the next tier after USA and Europe, since typically Canada represents about 10% of the market size …

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FDA’s eCTD Mandate: Are You Ready?

When FDA posted their eCTD mandate last year, it was more of a whisper than a bang.  It certainly did not wreak havoc in the industry; after all, we were all warned that the time would come sooner rather than later. The deadlines are quite clear: After May 5, 2017 The following submission types must …

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